Complex surgical device for carrying out and protecting an anastomosis

ABSTRACT

The present invention relates to a complex surgical device for carrying out an anastomosis in the intestine including:a—a protective device (5) comprising an anchor element consisting of a stent (1) and a flexible outer sheath (2), andb—an introducer (10) comprising at least a first deformable guide tube (12),characterized in that the downstream end of said outer sheath is connected to said first guide tube (12) or to a first connecting piece (11), said outer sheath (2) being folded inside said first deformable guide tube (12), said stent being held in radial compression inside said first deformable guide tube.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/647,152, filed Mar. 13, 2020, now U.S. Pat. No. 11,589,869, which isa U.S. national stage application of PCT/FR2018/052388, filed Sep. 28,2018, which claims priority to French Patent Application Serial No.1759847, filed Oct. 19, 2017, the entire contents of each of which areincorporated herein by reference.

The present invention relates to a complex surgical device useful forcarrying out and protecting an intestinal anastomosis.

Colorectal anastomoses have a disunion rate of about 20%. Disunion of ananastomosis (fistula) is a serious complication with a mortality rate ofabout 20%. To reduce the deleterious consequences of anastomoticfistulas, some patients benefit from an outlet (a stoma) between theskin and the intestine located upstream of the anastomosis to divert thedigestive flow into an external pouch and avoid contact between theanastomosis and the feces. The stoma is closed in a second step afterthe anastomosis has healed. The presence of a stoma and the need forre-intervention to remove it is a significant burden on the patient anda significant source of health expenditure.

It is in this context that an anastomosis protection device described inFR 2 941 858 and EP 2 395 942 has been provided which allows fecalmatter to be diverted into the intestinal lumen and ostomies avoided.The device consists of a flexible outer sheath attached to a stentdownstream of the stent, the stent being intended to be anchoredupstream of the anastomosis. The stent is the temporary anchor elementto the walls of the intestine, which holds the sheath in place and thesheath serves to divert fecal matter towards the anal orifice withoutcontact with the intestinal wall at the anastomosis and thus protect theanastomosis.

In WO 2013/014353, this device was further developed by adding means tocontrol the anchoring or release of the stent from the intestinal wall.To do this, the device's anchorage or release is reinforced by means ofa tube opening into the space of a chamber delimited between an innersheath and the stent wall, which makes it possible to create a suctioneffect by drawing the walls of the intestine against the stent toreinforce the anchorage or, on the contrary, to insufflate air or afluid to release it.

To do this, the surgical device of WO2013/014353 essentially consists oftaking advantage of the viscoelasticity of the intestine to attract itsinner wall towards the outer wall of the stent. Indeed, the intestinalmucosa is flexible and elastic while the stent walls are relativelyrigid. The intestinal wall can be attracted (by suction) and bonded tothe outer walls of the stent under the effect of negative pressure inthe stent-mucosa interface. In this case, the frictional force betweenthe intestine and the stent increases rapidly and significantly due to akind of suction effect. As a result, the mobility of the stent becomesclosely related to the suction effect, the modulation of which theninfluences the behavior of the stent in the intestine.

More precisely in this patent WO 2013/014353 a surgical anchoring deviceis described, capable of anchoring itself to the mucous membrane of theinternal wall of the intestine comprising;

-   -   (a) a temporary anchor element whose anchoring can be modified        in a controlled manner, comprising at least a first semi-rigid        hollow longitudinal element of the stent type, defining a wall        of revolution about a longitudinal axis comprising a        substantially cylindrical multi-perforated current part with a        substantially circular cross-section called the first wall, said        first hollow longitudinal element being made of a material        giving it radial elasticity properties so that it can be        radially compressed in a retracted position and adopt a said        position of maximum radial expansion after release of the radial        compression such that said first multi-perforated wall has a        first external diameter which can be varied in a controlled        manner between:    -   a first minimum external diameter in said retracted radial        position of said first wall of not more than 20 mm, preferably        not more than 10 mm, and    -   a first maximum external diameter at said maximum radial        expansion position of said first wall, preferably 18 to 45 mm,        and    -   (b) a flexible outer sheath attached to said stent and extending        from its downstream end,    -   characterized in that at least part, preferably the entire        length, of the cylindrical inner surface of said first wall is        lined with an independent sealing layer forming an inner sheath,        only the longitudinal ends of said inner sheath being attached        in a sealed manner to said anchor element by means of first        sealing means, preferably by joint fusing or an annular seal of        elastomeric glue, at each said longitudinal end of said inner        sheath, so as to delimit a chamber referred to as a vacuum        chamber between said inner sheath and said first wall, said        temporary anchor element being coupled to a flexible or        semi-rigid tube referred to as an injection-suction tube,        extending outside said anchor element, an open end of said        injection-suction tube opening into said vacuum chamber.

More particularly, said injection-suction tube is connected, preferablyreversibly at its free longitudinal end, to a connecting endpiece,itself reversibly connected or capable of being reversibly connectedwith a device for injecting or sucking up air or liquid such as asyringe, said connecting endpiece comprising a shut-off device,preferably an anti-backflow valve, and a vacuum indicator device capableof indicating the content of the vacuum in said vacuum chamber, inparticular located on a vacuum ampoule.

Said chamber defines a sealed chamber between the sealed film of theinner sheath and the intestinal wall when said anchor element is in aposition of maximum expansion and immobilized by anchoring against theinner surface of the intestinal wall. And, in the event of detachment ofsaid anchor element and/or in the event of migration of said anchorelement inside the intestine, said chamber loses its seal. However, aircan then be sucked through said tube from its free end from the outsideof the patient in order to draw the intestinal wall against the externalsurface of said first wall over a part or even over the entire externalsurface of said first wall delimiting said chamber in order to stop themigration of the anchor element by restoring the vacuum in said chamberand thus the sealing of said chamber.

Said anchor element may be held in a radially retracted position with aninstrument called an “introducer” described below, the radial expansiontaking place after the anchor element has been released from theintroducer.

In WO 2013/014353, the introducer can be in a known manner constitutedby a semi-rigid guide tube, of the catheter type provided at one of itsends with a handle and whose internal diameter and length make itpossible to keep housed therein said anchor element in its retractedform and said sheath, preferably longitudinally extended.

In WO 2013/014353, for anal introduction, said device further comprisesan introducer instrument comprising:

-   -   a tubular outer sheath capable of containing and holding said        anchor element compressed in said retracted position and said        injection-suction tube within the distal end of said outer        sheath, and long enough to further contain said sheath and said        injection-suction tube, said outer sheath preferably being at        least 70 cm long, preferably at least 100 cm, and    -   means for routing the distal end of said introducer from the        anal orifice to said anchoring site in the intestine upstream of        the anastomosis, and    -   preferably means for disengaging said anchor element from the        outer casing, preferably still consisting of a stop tube having        a stop at its distal end, in contact if necessary with the        longitudinal end of said anchor element, said sheath downstream        of the anchor element surrounding said stop tube inside said        outer casing.

An anastomosis is performed in the known manner with a stapler byinserting a circular cross-section part called an “anvil” into theintestine upstream of the anastomosis site, at the level of the free endof the intestine then tightening a wire known as “purse string” aroundthe anvil shaft before engaging the stapler body in the downstream partof the anastomosis up to the level of the anvil shaft to make thecircular stapler cooperate with the anvil for the sectioning of thetissues and the placing of the staples.

In these earlier patents cited above, the anastomosis protection deviceis therefore placed in the intestine once the anastomosis has beencarried out with a stapler, for example of the type described in FR 2846 868. It is by means of a flexible introducer that the device isintroduced through the anal orifice and then the anastomosis and thenthe intestine located upstream of the anastomosis. After removal of theintroducer, the stent opens in radial extension and comes into contactwith the walls of the intestine while the sheath and suction tube deployin the lumen of the intestine from its anchoring site upstream of theanastomosis to the anal orifice through the anastomosis.

Despite the proven safety of these maneuvers, some surgeons remainreluctant to introduce an object through a fresh anastomosis asdescribed in WO 2013/014355.

According to the present invention, a protective device is providedwhich can be introduced into the intestine even before the anastomosisis made, this also in order to facilitate the anastomosis with the anviland stapler, to reduce the number of steps during the surgical procedureand to reduce the operating time.

To this end, in principle, the object of the present invention is:

-   -   means for placing the anastomosis protection device in the        intestinal lumen upstream of an anastomosis not requiring        instruments introduced through the anal orifice and through the        freshly performed anastomosis but using excision of pathological        intestine and opening of the upstream intestinal lumen required        for the stapler anvil for prior placement of the anastomosis        protection device, and    -   means for deploying the anchoring device, the outer sheath and,        if applicable, the suction tube through the anastomosis only        after the anastomosis has been performed, the deployment of the        sheath and the suction tube taking place by and with the removal        of the stapler, i.e. after the steps of:    -   closing the upper intestine on the axis of the anvil by means of        a purse string,    -   introducing the stapler body through the anal orifice into the        downstream intestine, and    -   securing the anvil to the stapler body,    -   stapling, and    -   removing the anvil and stapler through the anal orifice.

For this purpose, the present invention more precisely provides acomplex surgical device consisting of a ready-to-use assembly forperforming an anastomosis in the intestine with an anvil and a circularstapler and then protecting said anastomosis in the intestinecomprising:

-   -   (a) a protective device comprising an anchor element consisting        of at least one stent capable of being temporarily anchored to        the inner wall of the intestine upstream of the anastomosis and        a flexible outer sheath, at least the upstream end of which is        fixed to said stent, said outer sheath being capable of        extending downstream of said anchor element and downstream of        said anastomosis in order to allow said anastomosis to be        protected, in particular after said anastomosis has been        performed and said anvil and stapler have been removed, and    -   (b) at least a first tube, called first guide tube, said stent        being held in radial compression within said first tube,        preferably at a distal end of said first guide tube, said first        tube being part of a guide tube of an introducer device or being        adapted to be reversibly attached to an introducer device, said        first tube being deformable in curvature relative to its        longitudinal axis (XX′),    -   characterized in that said flexible sheath is stored, preferably        folded, inside said first guide tube, and possibly partly, or        even entirely, inside said stent, the downstream end of said        sheath being connected to said first guide tube or to a first        connection piece independent of said first guide tube, said        flexible sheath being able to be deployed downstream of said        stent by withdrawing the proximal end of said first guide tube        or respectively to said first connection piece to which it is        fixed.

More particularly, the proximal end of said first guide tube orrespectively said first connecting piece comprises reversible fixingmeans such that said proximal end is capable of being fixed in areversible manner to a said anvil, said flexible sheath being capable ofbeing deployed downstream of said stent by the withdrawal of said anvilfixed in a reversible manner to the proximal end of said first guidetube or respectively to said first connecting piece.

More particularly, the proximal end of said first guide tube orrespectively said first connecting piece comprise means for reversibleattachment to the front face of a said anvil by gluing, screwing,clamping or magnetic connection. It is understood that the removal ofsaid anvil implies the prior disassociation of said anvil with respectto said proximal end of said first guide tube or respectively of saidfirst connecting part.

In a known manner, a said introducer comprises at least (i) said firstdeformable guide tube, (ii) a second rigid guide tube, the proximal endof said first deformable guide tube being attached or attachable to thedistal end of said second rigid guide tube, (iii) a handle connected tothe proximal end of said second rigid guide tube, and (iv) a pusherextending from said handle within said second rigid guide tube and saidfirst deformable guide tube comprising a pusher rod and a pusher stop atthe distal end of the pusher rod.

In a known manner, said introducer is capable of allowing theimplantation of the protective device upstream of the anastomosis site,said pusher stop being capable of pushing said protective device outsidethe distal end of said first deformable guide tube to allow the radialextension and anchoring of said stent against the wall of the intestine,the proximal end of said pusher rod being capable of cooperating withsaid handle by manually controlling a relative translation of saidpusher rod with respect to the first deformable guide tube.

In the prior art, this type of introducer is used to introduce the stentonly after the anastomosis has been performed and said first deformableguide tube is longer than according to the invention because it mustextend from the anal orifice to upstream of the anastomosis, i.e. inpractice at least 45 cm.

According to the present invention, the introducer is used to introducethe stent before the anastomosis is carried out so that the length ofsaid first deformable guide tube is for example no more than 30 cm, inorder to place the stent upstream of the anastomosis site.

Thus the removal of the introducer after anchoring of said protectivedevice upstream of the anastomosis makes it possible to partially deploysaid sheath in the intestine downstream of the anastomosis, the completedeployment of said external sheath taking place during the removal ofthe stapler, via the anal orifice. Indeed, after the removal of theparts of the introducer other than said first connecting piece or saidfirst tube of the introducer attached to said outer sheath, the lattermay be reversibly attached directly or indirectly to a stapler anvil inorder to perform the anastomosis as explained below.

More particularly still, when the downstream end of said sheath isattached to a said first connecting piece, said first connecting pieceis positioned just downstream of said stent, and said means forreversible attachment of said first connecting piece, may servesuccessively to:

-   -   −1) attaching to an abutment of a pusher of said introducer        during the initial phase of introduction to release said stent        out upstream of said first guide tube at the end of the initial        phase of introduction under the effect of the thrust of said        pusher, said stent thus being found in the upstream intestine at        a certain distance preferably 10 to 20 cm upstream of the        anastomosis site, then    -   −2) to be fixed to a said anvil after detachment and withdrawal        of said pusher and of the assembly of said introducer, to allow        said anastomosis to be performed with a stapler, optionally        after partial deployment of said sheath downstream of the stent        by withdrawal of said pusher up to the level of the site of the        anastomosis before detachment of said pusher, the complete        deployment of said sheath downstream of said anastomosis        resulting from the withdrawal of the assembly integral with said        first connecting parts, said anvil and said stapler after said        anastomosis has been performed.

More particularly still, when the downstream end of said sheath isconnected to said first tube, said first tube is capable of beingreversibly attached to an introducer device, said reversible attachmentmeans at the proximal end of said first guide tube serving successivelyto:

-   -   −1) be fixed to the end of a second guide tube of the        introducer, which is integral with the handle and the pusher,        during the initial phase of introduction, then    -   −2) to be fixed to said anvil, after detachment of said first        guide tube and removal of the remainder of said introducer        including removal of said pusher, to allow said anastomosis to        be performed with an anvil and a stapler, optionally after        partial deployment of said sheath downstream of the stent by        moving back from said first tube to the site of the anastomosis,        the complete deployment of said sheath downstream of said        anastomosis resulting from the complete removal of the assembly        integral with said first guide tube, said integral anvil and        said stapler, after said anastomosis has been performed.

The invention is more particularly advantageous when the protectivedevice comprises at least one flexible tube called a suction tube,preferably two suction tubes, each suction tube being capable ofextending outside said stent downstream thereof, in particular aftercarrying out said anastomosis and removing said anvil and stapler, anopen end of said suction tube opening into the interior of the stent ina vacuum chamber delimited between the inner wall of the stent and aninner film covering the inner wall of the stent, preferably said filmconstituting an extension of said sheath, characterized in that eachsaid suction tube is stowed, preferably folded, preferably furtherhelically wound inside said first guide tube, and optionally partly oreven entirely inside said stent, the downstream end of each said suctiontube being connected to said first guide tube or to a said firstconnecting piece, each said suction tube being capable of being deployeddownstream of said stent by the removal of said anvil reversiblyattached to the proximal end of said first guide tube or respectively tosaid first connecting piece.

The open end of the suction tube preferably consists of a terminal partof the tube within said chamber perforated by multiple perforations.

The use of two suction tubes increases the anchoring force and protectsagainst failure of the first suction tube, for example if the firstsuction tube becomes blocked.

More particularly, a complex ready-to-use device according to theinvention can be implemented in a surgical treatment process with theaid of a complex surgical device according to the invention in which thefollowing successive steps are carried out in which:

-   -   S1) said surgical device is introduced into the intestine by the        abdominal route in the part of the intestine upstream of the        anastomosis site with an introducer device comprising or        attached to a first guide tube and said anchor element is        released upstream of the anastomosis site by actuating a pusher        inside said first guide tube,    -   S2) the parts of said introducer other than said first guide        tube or other than a said first connecting piece to which or        respectively to which said sheath and said suction tube are        attached are removed from the intestine,    -   S3) a stapler anvil is inserted which is reversibly fixed to the        proximal end of said first guide tube or to said first        connecting piece,    -   S4) the sectioning of the intestinal tissue of the anastomosis        area and the preparation of the anastomosis is carried out by        stapling with a stapler cooperating with the anvil,    -   S5) the stapler attached to the anvil, itself attached to said        first tube or to said first connecting piece is removed, which        causes said sheath and said suction tube to deploy, and    -   S6) after passing through the anal orifice, the downstream ends        of said outer sheath and said suction tube are disengaged,        preferably with scissors, from said first guide tube or said        first connecting piece, outside said anal orifice, and    -   S7) the downstream end of the suction tube is connected to a        device outside the patient capable of maintaining the vacuum in        the vacuum chamber and thus preventing migration of said anchor        element.

This procedure is particularly useful for the temporary protection of ananastomosis on the large intestine or colon, rectum or anal canal, toprevent or reduce the risk of anastomotic fistula. In this case,preferably, the distance between said anchoring position upstream ofsaid anastomosis and said anastomosis is at least equal to 10 cm. Moreparticularly, the distance between the anastomosis and the anchoringsite is at most 20 cm.

As explained below, the device according to the invention, because ofits possible implantation before the anastomosis is performed, makes itpossible to implement a stent and a sheath of reduced dimensions on theone hand and therefore implanted at a reduced distance upstream of thesite of the anastomosis compared to what was required in previousdesigns such as in WO 2013/014355, in particular at a distance of only10 to 20 cm.

The term “anastomosis protection”, as used here, means protection of theanastomosis when the intestinal transit is resumed.

“Downstream” and “upstream” refer here to the direction of travel fromupstream to downstream of intestinal transit and to a position when thedevices concerned are in place in the intestine to fulfil theirfunction. By “downstream end” of said sheath, it is understood that itis the end intended to be deployed in said stent once deployed afterremoval of the stapler after completion of the anastomosis, even if thisdownstream end is initially brought closer to the upstream end in orderto be fixed to the inner wall of the first guide tube.

The terms “proximal” and “distal” refer here to the position in or ofthe element concerned in relation to the site of initial introductioninto the patient's body and in practice here also in relation to thehandle of the introducer with regard to the elements of the introducer.The proximal and upstream ends correspond to the downstream and upstreamends respectively for introduction through the anal orifice or a part ofthe intestine downstream of the anastomosis.

In this case according to the invention, only the first deformable guidetube of the introducer and part of said second rigid guide tube areintroduced into the lumen of the part of the intestine upstream of theanastomosis, the rest of the second rigid guide tube and the handleremaining outside the intestine.

The term “first deformable guide tube” of the introducer means inpractice a semi-flexible tube made of elastomer or PU material thickerthan said sheath and deformable by bending in relation to itslongitudinal axis until it can adopt a 90° external curvature. Thisfirst deformable guide tube has graduations enabling the implantationsite to be checked before release.

More particularly, in a known manner, said sheath is fixed in a sealedmanner to said anchor element by means of sealed fixing means,preferably by fusing joint or an annular joint of elastomer glue, ateach said longitudinal end of said inner sheath, so as to delimit avacuum chamber between said inner sheath and said first wall, saidtemporary anchor element being coupled to said flexible or semi-rigidtube called suction tube, extending outside said anchor element, an openend of said suction tube opening into said vacuum chamber.

In a first embodiment, the downstream end of said sheath and thedownstream end of said suction tube(s) are connected to the distal endof said first guide tube, the proximal end (or downstream end) of saidfirst guide tube comprising a second connecting piece fixed or capableof being fixed in a reversible manner to the distal end (or upstreamend) of a second rigid guide tube of an introducer device for theintroduction of the protective device upstream of the site of theanastomosis and then capable of being fixed in a reversible manner to asaid anvil for carrying out the anastomosis.

The second connecting piece is fixed or capable of reversibly fixingsaid first guide tube to the distal end of a second rigid guide tube ofan introducer device in order to connect them for the introduction ofthe protective device upstream of the anastomosis site and then todisconnect them for the removal of the introducer before the anvil andstapler are used.

In this first embodiment, said first guide tube comprising a secondconnecting piece at its proximal end remains inserted in the intestineduring the making of the anastomosis and is withdrawn from the intestinewhen the stapler is removed after the making of the anastomosis becauseof its connection with the anvil thus allowing the complete unfoldingand deployment of said sheath and said suction tube downstream of saidstent because of their connection with said first tube.

More particularly, in this first embodiment, the downstream end of saidsheath and the downstream end of said suction tube(s) are connected tothe distal end (or upstream end) of said first guide tube by adhesivebonding or by a thread.

In this first embodiment, more particularly, the sheath and the suctiontube(s) are entirely arranged, in particular folded or rolled, insidethe stent except for their downstream parts which leave the stent at itsdownstream end to join the upstream end of the first guide tube upstreamof the stent, these external parts of the sheath and the suction tube(s)being interposed between the stent and the internal wall of the firstguide tube.

More particularly, in this first embodiment, said second connectingpiece is fixed or capable of being fixed in a reversible manner to anadapter which is itself capable of being fixed in a reversible manner toa stapler anvil.

More particularly still, in this first embodiment, said secondconnecting part is fixed or capable of being fixed in a reversiblemanner by screwing, gluing, clamping or magnetic connection, to anadapter which is itself capable of being fixed in a reversible manner toa said stapler anvil, by gluing, clamping or magnetic connection.

More particularly still, in this first embodiment, said secondconnecting piece comprises a threaded element capable of cooperating byscrewing with:

-   -   a first complementary threaded element located at the distal end        of said second rigid guide tube, and then    -   a second complementary threaded element located at the distal        end of a said adapter.

It is understood that:

-   -   said second connecting piece is reversibly attached to the        distal end of said second rigid guide tube, during the        introduction and release of the protective device by said pusher        to allow the introduction and then anchoring of said stent in        the intestine upstream of the site of said anastomosis before        the anastomosis is performed, and    -   said second connecting piece is reversibly attached to said        anvil or a said adapter after removal of said pusher for        reversible attachment of the anvil to allow said anastomosis to        be performed with said stapler after said stent has been        anchored in the intestine upstream of the site of said        anastomosis.

More particularly, the flat proximal part of a said adapter is suitablefor attachment by adhesive bonding to the flat front face of a saidanvil.

In a second embodiment, the downstream end of said sheath and preferablythe downstream end of said suction tube(s) is (or are) connected to asaid first connecting piece, at least one proximal end of which isdisposed outside the downstream end of said stent.

More particularly, in this second embodiment, the downstream end of saidsheath and preferably the downstream end of said suction tube(s) is (orare) connected to a distal part of said first connecting pieceindependent of said first guide tube, preferably a tubular distalportion arranged or adapted to be arranged inside the downstream end ofsaid stent, and a proximal portion of said first connecting piece isarranged outside and at the downstream end of said stent preferablyhaving a flat proximal face of larger diameter than said tubular distalportion.

Thus, initially and during the introduction phase, said first connectingpiece is arranged inside said first guide tube.

In this second embodiment, more particularly, the sheath and the suctiontube are entirely stored inside the stent except for their swallowedparts which come out of the stent at its swallowed end to join the firstconnecting piece which is placed against the swallowed end of the stent.

In this second embodiment, the entire protective device and said firstconnecting piece are independent of the first guide tube and theintroducer.

More particularly, the downstream end of said sheath and the downstreamend of said suction tube(s) are connected to a said first connectingpiece by adhesive bonding or by a wire.

More particularly still, in this second embodiment, said firstconnecting part is adapted to be fixed in a reversible manner to a stopof a pusher rod inside said first guide tube when the protective deviceis introduced upstream of the anastomosis site, preferably by gluing,screwing, clamping or magnetic connection.

More particularly still, in this second embodiment, said firstconnecting part is suitable for reversible direct attachment to a saidanvil by gluing, screwing, clamping or magnetic connection, preferablyby adhesive bonding.

In this embodiment, the introducer device can be completely removed fromthe intestine after introduction of the protective device upstream ofthe anastomosis site before the anastomosis is carried out, only saidfirst connecting piece remaining introduced into the intestine to befixed to the anvil for the purpose of carrying out the anastomosis, saidfirst connecting piece being withdrawn from the intestine when thestapler is removed after the anastomosis has been performed because ofits connection with the anvil, thus allowing the complete deployment ofsaid sheath and of said suction tube(s) downstream of said stent becauseof their connection with said first connecting piece.

It is understood that:

-   -   said first connecting piece is reversibly attached to said        pusher stop during the introduction and release of the        protective device by said pusher to allow the introduction and        anchoring of said stent in the intestine upstream of the site of        said anastomosis before the anastomosis is performed, and    -   said first connecting piece is reversibly attached to said        stapler anvil or to a said adapter after complete removal of        said introducer to allow said anastomosis to be performed with        said stapler after said stent has been anchored in the intestine        upstream of the site of said anastomosis.

More particularly still, for both embodiments, the distal end of saidfirst guide tube is closed by a flexible retaining element capable ofretaining said protection device inside said first guide tube in theabsence of thrust by a pusher rod stop, said retaining element beingcapable of deforming elastically and allowing the exit of saidprotection device under the effect of the thrust by said pusher rodstop.

More particularly still, the complex surgical device according to theinvention comprises a said protective device and an introducer capableof allowing the implantation of the protective device upstream of theanastomosis site, said introducer comprising a handle fixed and/orcapable of cooperating with the two following parts of the introducer:

-   -   (b1) a first deformable guide tube within which said stent is        held in radial compression near the distal end of said first        deformable guide tube, the proximal end of said first deformable        guide tube being fixed to a second rigid guide tube integral        with said handle, and    -   (b2) a pusher comprising a pusher rod deformable in curvature        with respect to its longitudinal axis and a said pusher stop at        the distal end of the pusher rod extending from the handle        within said second rigid guide tube and said first deformable        guide tube, the proximal end of said pusher rod being adapted to        cooperate with said handle by manually controlling a relative        translation of said pusher rod with respect to the first        deformable guide tube.

More particularly, the pusher rod is a spiral rod formed by a steel wirewound helically along a virtual longitudinal axis XX′ with coaxialcontiguous turns of the same diameter, the diameter of the contiguousturns forming a deformable rod capable of being deformed in curvaturewith respect to said longitudinal axis to allow it to adopt a curvatureto form a 90° bend.

More particularly still, said stent comprises at least one withdrawalloop at one end of its longitudinal ends, preferably two loops at eachof its longitudinal ends.

The advantageous and novel features of the process for anchoring thestent and carrying out the anastomosis resulting from the novelstructural features of the complex surgical device according to theinvention are:

-   -   an anchoring of the protective device upstream of the        anastomosis site, with deployment of said sheath and said        suction tube and removal of the stapler in a single gesture        after an anastomosis has been performed by a surgical stapler,    -   no passage of the introducer through the fresh anastomosis, and    -   reduction in operating time.

More particularly, the suction tube is a semi-rigid tube, in particularmade of PE or PP, and has a length capable of holding in shape andextending inside the intestine from an anal orifice of the patient tosaid anchor element, preferably the length of said injection-suctiontube being at least 20 cm, more particularly from 50 to 150 cm, and thefree end of said suction tube outside the patient is connected to adevice for sucking or injecting gaseous or liquid fluid, in particularair or a cold liquid as explained below.

More particularly, the length of the outer sheath protects theanastomosis and protrudes from the anal orifice when said anchor elementis in the anchoring position and deployed downstream thereof.

Said outer sheath, due to its elastomeric constitution, has radial andlongitudinal stretchability properties similar to those of theintestinal wall, which properties are those of an elastomeric materialin the form of said sheath, the latter having radial and longitudinalelasticity properties. These radial and longitudinal elasticityproperties of the sheath are similar to those of the wall of the colon.

In a preferred embodiment, said runner portion of said first wallextends from the upstream longitudinal end of said first wall to aprofiled downstream end portion of smaller diameter than that of thecylindrical runner portion, the maximum radially expanding outerdiameter of the downstream end of said first wall being 20 to 40 mm, andthe length of said profiled end portion of the first wall being 10 to 30mm, preferably 15 to 25 mm, preferably the diameter of said end portiondecreasing progressively between said runner portion and said downstreamend of said first wall.

More particularly, said temporary anchor element is an enteralprosthesis, said first wall of which is formed by a mesh of spiralwires, preferably metal wires. In a known manner, the radial expansionthen results from the crossing of the metal wires, the angular variationof which makes it possible to vary the width of the rhombus orparallelogram of the meshes of said mesh of spiral wires.

Advantageously, said anchor element is made of a material which conferson it a said expansion by radial elasticity only at a temperature atleast equal to the ambient temperature of 20° C., in particular to thetemperature of the human body, said anchor element being in said radialposition retracted at a temperature lower than said ambient temperature,preferably lower than 5° C. It is understood that the material intubular form changes diameter automatically as a function of the ambienttemperature.

More particularly still, said anchor element is an enteral prosthesis,said first wall of which is formed by a mesh of spiral threads,preferably made of nitinol. Nitinol is a metal alloy having propertiesof progressive radial expansion as a function of temperature, at atemperature greater than or equal to room temperature (25° C.), whichmakes it possible to keep it in retracted form at colder temperatures,in particular at 4° C. during storage. Once retracted at lowtemperature, it thus remains retracted for sufficient time to be able tohouse it in the introducer tube and to convey it into the intestine bymeans of said introducer. Once released in the intestine, the prosthesisgradually regains its radial expansion under the effect of a higherambient temperature, that of the human body. In fact, for nitinolstents, the shape memory of this alloy makes it possible to modify itsshape and rigidity as a function of the ambient temperature. Inparticular, at temperatures below 15°, nitinol becomes flexible andmalleable. Thus, injecting a cold liquid solution between 0° and 15°into the vacuum chamber makes the stent malleable and facilitates itsmobilization during passage through the anastomosis or a narrowing zonefor example.

Advantageously, said sheath is made of biocompatible synthetic material,with a wall thickness of 0.01 to 1 mm, preferably of elastomer materialsof the silicone or polyurethane type with a thickness of 0.05 to 1 mm,and preferably still having radial and longitudinal elasticityproperties, and said outer sheath at least having shape memoryproperties and non-collision properties.

It is understood that said outer sheath, due to its elastomericconstitution, has radial and longitudinal stretchability propertiessimilar to those of the intestinal wall, which properties are those ofan elastomeric material in the form of said outer sheath, the latterhaving radial and longitudinal elasticity properties. These radial andlongitudinal elasticity properties of the outer sheath are similar tothose of the wall of the colon and allow the intestinal transit to takeplace correctly in said outer sheath throughout the duration ofmigration of the anchor element, which is a duration of at least 6 to 10days.

The longitudinal elasticity of the elastomeric outer sheath can begreater than that of the intestine, without this posing any difficulty.On the contrary, it has the advantage of being able to be pulled overthe part of the outer sheath protruding anal, so that it can be cut andretracted into the rectum. By virtue of its radial elasticity, saidlongitudinal end of the outer sheath remains fixed to said end of saidanchor element whatever its level of radial expansion.

On the other hand, the thickness characteristics of the outer sheathcombined with its elasticity give it a shape memory property. By “shapememory properties” is meant here that the elastomeric materialconstituting said outer sheath naturally regains its initial shape whenit is deformed by folding. Given the great length of the outer sheath,these shape memory properties are important, so that the materialnaturally regains its longitudinal shape without creating a transitblock in the event of folds in the outer sheath, which may actuallyoccur during its migration after release of the anchor element.

“Non-sticking properties” means that the elastomeric materialconstituting said outer sheath has a coefficient of adhesion such thatthe two opposite inner wall surfaces of the outer sheath do not sticktogether when folded, so as not to create any resistance to the passageof gases and materials.

It is also understood that:

-   -   said outer sheath has a resting diameter substantially equal to        at least said outer diameter reduced in radial retraction of        said hollow anchor element, and less than that of the resting        intestine, preferably said resting diameter of said outer sheath        is substantially equal to that of the resting intestinal wall,        and    -   said outer sheath extends downstream of the end of said anchor        element to which it is attached over a length corresponding to        the distance between the anchoring position upstream of said        anastomosis and a position downstream preferably to the anal        orifice.

In a known way, the radial expansion then results from the crossing ofthe wires whose angular variation makes it possible to vary the width ofthe diamond or parallelogram of the meshes of said mesh of spiral wires.

Preferably, and in a known manner, a stent is used whose design andshape of the mesh of the spiral wires make it possible to obtain avariation in the diameter of said stent with a minimum variation inlength, preferably practically without variation in length at radialcompression.

Other features and advantages of this invention will be better apparentfrom the description that follows, which is illustrative and notexhaustive, with reference to the following appended drawings.

FIGS. 1A, 1B and 1C represent schematic views of a protection device 5according to the invention comprising a side view with the sheath 2 andsuction tube 3 deployed downstream of the stent 1 (FIG. 1A), a frontalview of the upstream or distal end of the stent 1 mounting a lasso loop6 b (FIG. 1B) and a longitudinal cross-sectional view of the protectiondevice 5 showing the respective positions of the stent 1, the sheath 2and the suction tube 3, the latter opening into a chamber 4 between thewall of the stent and the inner part 2 a of the sheath 2.

FIG. 2 shows the different parts of a dismantled introducer device 10.

FIG. 2A shows the introducer device 10 with the first guide tube 12inserted into the upstream part of the intestine 100 a.

FIG. 2B shows the release of the stent from the first guide tube 12 bythe thrust of the pusher rod 15 (not visible in FIG. 2B).

FIGS. 3A and 3B show a detail of a deformable pusher rod 15 b with aspiral shape in side view (FIG. 3A) and in front view of one of its ends(FIG. 3B).

FIGS. 4A to 4D show the different steps of placing an anvil 8 andstapling an anastomosis 101 between the upstream part 100 a and thedownstream part 100 b of the intestine with a stapler 9 cooperating withan anvil 8.

FIGS. 5A-5B, 6 and 7A-7D relate to the embodiment of Example 1.

FIGS. 5A and 5B show two variants in schematic sectional views(partially exploded for FIG. 5A) of a protective device 5 with the stentcompressed at the distal end of the first tube 12 in which the sheath 2and the suction tube 3 are folded inside the stent, their downstreamends being stuck to the distal end of the first tube, the protectivedevice 5 being ready to be expelled by the stop 15 b of the pusher 15out of the first guide tube 12.

FIG. 6 schematically shows stent 1 released externally with the firstguide tube 12 separated from the rest of the introducer and emptied fromthe push rod after release of the stent and deployment of the sheath 2and the suction tube 3 downstream of the stent 1 due to the removal ofthe first guide tube 12 to which they are attached.

FIGS. 7A to 7C show the different steps for placing the anvil at theproximal end of the first guide tube 12 before anastomosis is performed.

FIG. 7D shows the removal of the stapler attached to the first tube 12allowing the deployment of the sheath 2 after anastomosis.

FIGS. 8A-8B, 9A-9B, 10A-10C and 11A-11B represent the embodiment ofExample 2.

FIGS. 8A and 8B show two alternatives for attaching the suction tube 3and the sheath 2 to a first connecting piece 11 downstream of the stent1 and independent of the first guide tube.

FIGS. 9A and 9 b show a protective device 5 with the stent 1 at thedistal end of the first guide tube 12 and the sheath 2 and the suctiontube 3 attached to an adapter 11 itself reversibly attached to the stop15 b of a pusher 15.

FIGS. 10A, 10B and 10C show different steps of the removal of theintroducer 10 including the first guide tube 12 after release of thestent 1 and partial deployment of the sheath 2 and the suction tube 3connected to the first connecting piece 11. FIG. 10B shows the approachof the anvil 8 to the first connecting piece 11. FIG. 10C shows thefixation of the anvil 8 in the upstream bowel 10 a before anastomosis isperformed with the stapler 9.

FIGS. 11A and 11B show the stapler 9 with the anvil 8 attached to thedownstream ends of the sheath 2 and the tube 3 when performing theanastomosis 101 (FIG. 11A) and after removal of the stapler andseparation from the first connecting piece 11 after carrying out theanastomosis 101 (FIG. 11B). In the two embodiments of Examples 1 and 2below, an anastomosis protection device 5 of FIGS. 1A-1C of the typedescribed in WO2013/014353 packaged in a part of an introducer device asdescribed below with reference to FIGS. 2, 2A-2B and 3A-3B is used toperform an anastomosis described with reference to FIGS. 4A-4C.

The anastomosis protection device 5 comprises an anchor elementconsisting of a stent 1 whose inner wall is covered by a flexible innersheath 2 a delimiting an annular chamber 4 between annular seals 4 a-4 bwhich seal between the inner sheath 2 a and the perforated wall of thestent. The inner sheath 2 a constitutes a sealed film forming a flexibletubular wall and is extended by a flexible outer sheath 2 extendingoutside said anchor element in the longitudinal direction of said stent.The entire length of the cylindrical inner surface of the inner wall ofthe stent is thus doubled by an independent sealing layer forming aninner sheath 2 a, only the longitudinal ends of said inner sheath 2 abeing attached in a sealed manner to said anchor element 1 by means ofthe elastomeric annular seals obtained by fusion at each saidlongitudinal end of said inner sheath.

As is well known, the stent 1 advantageously includes flared flanges atits upstream and downstream ends as shown in patent WO 2013/014353.

It is understood that the inner sheath 2 a is not overstretched so asnot to stiffen the stent, so that the distance between said inner sheath2 a and the maximum external diameter of the stent is preferably 0.2 to10 mm, preferably 1 to 5 mm, and the space between said inner sheath 2 aand said stent wall defines a chamber called the vacuum chamber 4.

The protective device 5 according to the invention further comprises aflexible or semi-rigid tube called suction tube 3 extending externallydownstream of said stent and opening into the vacuum chamber 4 betweenthe inner sheath 2 a and the wall of the stent 1, an upstream part ofthe suction tube 3 comprising multiple perforations, extendssubstantially over the entire length of said chamber 4 in thelongitudinal direction XX of the device. The suction tube 3 opens intosaid vacuum chamber by passing in a sealed manner through theelastomeric annular seal at the downstream end of the inner sheath 2 awhen the tube 3 is introduced through the anal orifice. Said suctiontube 3 and said outer sheath 2 extend outside said stent from the samedownstream end of said stent.

The suction tube 3 is used to inject or suck air into the chamber 4 todraw the intestinal wall 100 a against the outside of the stent 1, andmore generally to modify the anchoring characteristic of the stent 1 inrelation to the intestinal wall 100 a.

The portion 3 a of the suction tube 3 inside chamber 4 can be bonded tothe inner side of the stent 1 or to the outer side of said outer sheath2.

Alternatively, the outer sheath 2 can be attached at its upstream end tothe same elastomeric fusion joint 4 a-4 b or can be attached to theouter face of the downstream longitudinal end of the stent byoverlapping it over a short portion of its length (not shown in thefigures).

The stent of the type made by spiral meshing of nitinol metal wiresgiving it radial elasticity properties so that it can be radiallycompressed in a retracted position and adopt a said maximum radialexpansion position after release of the radial compression such thatsaid first multi-perforated wall has a first external diameter which canbe varied in a controlled manner between:

-   -   a minimum outer diameter in said retracted radial position of        said first wall of 16 mm, and    -   a maximum external diameter at said maximum radial expansion        position of said first wall of 37 mm.

The dimensional data for the diameters given above correspond toappropriate dimensions for anchoring the device against the mucousmembrane of the inner wall of the intestine 10 at various positionsbetween including the rectum. The stent is made of a mesh of 0.32 mmnitinol wires braided at an angle of 30° and has a diameter of 34 mm atthe running part and 37 mm at its flared ends, a length of 100 mm.

The proximal and distal parts of the stent, and where applicable theflanges (not shown), are each equipped with a lasso wire 6 a, 6 b toreduce the diameter of the stent in traction. These lassos wires 6 a, 6b can be grasped with a dedicated clamp or hook inserted via anendoscope.

Said sheath 2 extending outwards has a length covering the distancebetween the anastomosis and the upstream anchorage site, i.e. at least10 cm.

The sheath 2 is made of biocompatible synthetic material, radiopaque, inparticular TPU 90 AE with 18% BaSO₄, its dimensional characteristicsare: thickness of 100 μm, resting length of 400 mm (excluding theinternal part of the stent), and external diameter of 37 mm.

Said suction tube 3 made of Pebax® elastomeric material (ARKEMA, France)is attached to the stent by the same fusion joints 4 a-4 b as the innersheath 2 a at the ends of the stent and has a length covering at leastthe distance between the anastomosis and the upstream anchorage site,i.e. at least 10 cm. Its characteristics are length of 500 mm±2 mm;thickness of 05 mm; internal diameter of 2 mm; and external diameter of3 mm.

The outer free longitudinal end of said suction tube 3 is reversiblyconnected to a connecting piece having a shut-off device consisting ofan anti-backflow valve with a device for indicating the vacuum contentin the chamber 4.

The stent 1, the outer sheath 2 and the injection suction tube 3 arepackaged in a semi-rigid plastic deformable tube 11 made of elastomermaterial, hereinafter referred to as the first deformable guide tube 12.This first guide tube 12 is part of an introducer device 10 describedbelow.

The stent is introduced in retracted form (radially compressed) at theupstream distal end of said first deformable guide tube 12, said outersheath 2 and said suction tube 3 being arranged folded back onthemselves in several superimposed layers partly inside the stent andpartly inside the first guide tube 12 of the introducer 10.

The fixing of the downstream ends of the outer sheath 2 and the suctiontube 3 are different in the two embodiments of Examples 1 and 2, thefirst guide tube 11 having distinctive characteristics of implementationbetween the two embodiments which will be explained below. The stent isretained inside the first guide tube 12 by a device called a tulip 12 aformed of cut-out tabs blocking the passage of the upstream or distalend of the first guide tube 12, which prevents the stent from coming outin the absence of a thrust by the pusher stop described below, said tabsbeing elastically deformable under the effect of a said thrust enablingthe stent to be expelled outside the first guide tube 12.

The introducer device 10 comprises a handle 14 which is attached to asecond rigid tube 13 also referred to as the second guide tube,terminating at its distal end in a connecting part 13 a with the firstguide tube 12. This connecting part 13 a is convexly curved externallyand is larger in diameter than the first deformable guide tube 12 andsecond rigid guide tube 13 to serve as a stop.

A means of actuation by pressure or push button 14 a on the handle 14controls the longitudinal translation of a pusher rod 15 a ending in apusher stop 15 b of a pusher 15. The pusher rod 15 a and the pusher stop12 b are arranged coaxially inside the second rigid tube 13. Theproximal end of the pusher rod 15 a cooperates with the push button 14 aon the handle 14. The distal end of the pusher rod and the pusher stopare capable of expelling the stent out of the upstream end (distal end)of the first deformable guide tube 12 by actuation of the pusher rod andpusher stop in relative transaction inside the first deformable guidetube 12.

The pusher stop 15 b is initially positioned just downstream of thestent inside the first deformable guide tube 12.

In the two embodiments of Examples 1 and 2 below, the first deformableguide tube 12 of the introducer containing the protective device 5radially compressed as described above is introduced abdominally intothe upstream part 100 a of the intestine which has been sectioned at thesite 101 where an anastomosis is to be carried out. In this case, theimplantation site is located at a distance of 10 cm to 20 cm upstream ofthe anastomosis.

At this stage, the stent as well as the outer sheath 2 and the suctiontube 3 are still packed inside the stent, at least in part, and insidethe first deformable guide tube 12. In its initial form, closed andhoused in the introducer, the stent 1 has a diameter reduced to thediameter of the deformable guide tube 11, i.e. in particular 10 mm.

Once released outside the first deformable guide tube 12 into the lumenof the upstream intestine 100 a, the stent gradually regains its finaldiameter. It can be temporarily held in place by the surgeon, whopinches the stent through the walls of the intestine. At least part ofthe introducer is then removed without the outer sheath 2 and thesuction tube 3 being unfolded and deployed downstream of the stent.However, these elements can be partially deployed up to the anastomosiszone (the stent is released 10-20 cm above this zone). This is to allowthe anastomosis to be performed before the outer sheath and suction tubeis unfolded and deployed more fully downstream of the stent. The releaseof the stent outside the first deformable guide tube 12 into the lumenof the intestine, with the stent gradually regaining its final diameter,is done at this stage, ideally before the anastomosis is performed.

Said first deformable guide tube 12 has an internal diameter of 10 mm,an external diameter of 17 mm and a length of at least 70 cm, preferablyat least 100 cm with a graduation every 5 cm. It is made of Pebax®material to limit friction during insertion and removal.

The second rigid tube 13 has a length of 176 mm including the connectingpart 13 a curved convex with a protruding diameter of 53 mm forming astop and a length of 46 mm. The second rigid tube 13 has a central guidegroove 13 b controlling the translation of the inner pusher rod.

The shaft 15 a of said pusher 15 is made of stainless steel and has alength before the stop 15 b of 487 mm. The rod 15 a is a rod formed of awire of 1.4 mm diameter wound helically along a virtual longitudinalaxis XX′ with adjoining turns, the diameter of the adjoining turnsforming a deformable rod with an external diameter of 7 mm. Such a rod15 a can be deformed in curvature to allow a bend of up to 90°.

FIGS. 4A to 4D show the various steps involved in making an anastomosiswith an anvil 8 and a circular stapler 9. An anvil 8 is inserted intothe upstream part 100 a of the intestine just upstream of theanastomosis site 101 at the free end of the upstream intestine part 100a. Then, ligation of this free end of the intestine is performed with apurse string 8′ around a shaft 8 b behind the circular cross-sectionpart 8 a of the anvil 8. Then, a stapler 9 is introduced into thedownstream part 100 b of the intestine, which comprises a hollow body 9b of circular cross-section intended to cover the circular part 8 a ofthe anvil and containing an axial finger 9 a capable of cooperating inan axial hollow (not shown) in the shaft 8 b, making it possible to thusto engage the stapler 9 to cooperate with the anvil 8 to performstapling at the anastomosis 101 between the upstream part of theintestine 100 a and the downstream part 100 b of the intestine beforethe anvil 8—stapler 9 assembly is removed from the intestine as shown inFIG. 4D. In FIGS. 4B to 4D, the stapler 9 is shown downstream of adownstream segment of the intestine as a schematic illustration with theunderstanding that the stapler 9 is actually introduced initially viathe rectum. In particular, an EEA® stapler from the company COVIDIEN(France) is used, comprising a handle 9 d and a deformable duct 9 ccapable of following the curves of the intestine to connect the handle 9d to the stapler part 9 b which cooperates with the anvil 8 to controlstapling.

More precisely, the following successive steps are carried out:

-   -   1) the diseased intestine is resected using a linear stapler,        resulting in closure 100 d and sectioning of the intestine        downstream 100 b of the diseased intestine segment;    -   2) a purse string 8′ is applied to the intestine located        upstream of the diseased segment before cutting it;    -   3) the anvil 8 of a circular stapler is inserted into the upper        intestine 100 a and the purse string 8′ is tightened and knotted        around its central axis 8 b;    -   4) the body 9 b of the circular stapler is inserted into the        downstream intestinal segment 100 b (through the anal orifice)        up to its closed end 100 d;    -   5) the central axis 9 a of the circular stapler is pushed out        through the walls of the downstream intestine by penetration;    -   6) the central axis 9 a of the circular stapler is connected to        the central axis 8 b of the anvil;    -   7) the 2 pins 8 a-9 a joined together are inserted into the body        of the stapler resulting in the anvil section being attached to        the body section of the stapler; and    -   8) the walls of the 2 intestine segments 100 a and 100 b joined        together in 101 are stapled and sectioned in a circular section.        The end stop 15 b of the pusher is made of Pebax® material and        has a diameter and thickness in the longitudinal direction of        the rod of 10 mm.

In the two embodiments of Examples 1 and 2, the outer sheath 2 and thesuction tube 3 are unfolded and extended downstream of the stent byremoving the anvil after stapling has been performed.

Removal of the protective device should ideally take place after healingof the anastomotic area, the standard duration of which is 14 days.

Withdrawal can be done in 2 ways:

-   -   a) removal by reversal during an endoscopic procedure, In this        case, a lasso loop 6 b at the distal (or upstream) end of the        stent is grasped with forceps. This has the effect of reducing        the diameter of the stent. When the stent is fully retracted        radially, it is then possible to turn the stent over by pulling        on the lasso wire, which causes the stent to flip or invert,        while gradually pulling it away from the tissue.    -   b) the second method of withdrawal involves the use of a        withdrawal tube. In this case, the outer sheath and the suction        tube are inserted into a withdrawal tube. A lasso loop 6 a        located at the proximal (or swallowed) end of the stent is        grasped with forceps (this is guided by the use of an        endoscope). This has the effect of reducing the diameter of the        stent (by radial retraction). When the stent is fully retracted,        it is then possible to slide it into the removal tube. Advancing        the retraction tube allows the tissue to be loosened and the        stent to be collected atraumatically. The withdrawal tube        containing the stent is then removed by the anal route.

In the two embodiments of Examples 1 and 2, the connection configurationof some of the components of the introducer between themselves or withthe protection device 1 are different and in particular the downstreamlongitudinal ends of the outer sheath 3 and of the suction-injectiontube 4 are connected to an element of the introducer device which isdifferent. The downstream ends of the outer sheath 2 and of the suctiontube 3 are attached to the distal end of said first guide tube 12 in theembodiment of Example 1 and to a first connecting piece 11 capable ofbeing reversibly attached to the stop 15 b of the pusher in theembodiment of Example 2.

Example 1

In FIGS. 5A, 5B, 6 and 7A-7B, a first embodiment of a complex deviceaccording to the invention is shown in which the downstream ends of thesheath 2 and of the suction tube 3 are fixed in 2 b-3 b near theupstream or proximal end of the first deformable tube 12.

In FIG. 5A, the sheath 2 and the suction tube 3 are folded inside thestent 1 and protrude downstream of the stent beyond the seal 4 b to jointhe upstream end of the first guide tube 12 from the outside, with theends of the sheath 2 and of the suction tube 3 bonded against the innerwall of the first guide tube 12 in 2 b-3 b near the upstream or proximalend of the first guide tube 12.

FIG. 5B schematically shows an embodiment in which there are severalfolds of the sheath 2 and of the suction tube 3 inside the stent 1,which sheath 2 and suction tube 3 join the inner wall of the firstdeformable tube 12 by being interposed between the outer wall of thestent 1 and the inner wall of the first guide tube 12. In FIG. 5B, thepositioning of the stent 1 inside the first guide tube 12 has beenschematically illustrated by over-exaggerating the space between thestent 1 and the inner wall of the first guide tube 12 to show thepositioning of the sheath 2 and the suction tube 3 outside the stent 1,but in reality the stent 1 is in radial compression pushing against theinner wall of the first guide tube 12 with the sheath 2 interposed andwedged between them at this initial stage.

In this embodiment, the stop 15 b of the pusher 15 has a cross-sectionaldiameter slightly larger than the diameter of the stent and is thereforeable to expel the stent towards the exit of the proximal end 12 a of thefirst deformable guide tube 12 under the effect of the translationalthrust of the pusher 15 actuated at the handle 14 of the introducerdevice 10.

FIG. 6 shows the complete deployment of the sheath 2 and the suctiontube 3 downstream of the stent 1 when, after completion of theanastomosis described below in conjunction with FIGS. 7A-7D, thesituation is as shown in FIG. 7D with the first tube 12 removed from thebowel. In practice, this removal takes place until the stapler exitsthrough the anal orifice. At this point, as shown in FIG. 7D, the sheath2 and the suction tube 3 are cut with scissors 16 to separate them fromthe complex assembly of the first tube 12, which is attached to thestapler 9 by the second connecting piece 12 b.

In this embodiment, as shown in FIGS. 7A-7C, the proximal end of thefirst deformable guide tube 12 in fact comprises a part called secondconnecting part 12 b comprising an internal thread capable of screwingcooperation with a complementary thread element 7 a of a part calledadapter 7, the latter being capable of being fixed for example byreversible bonding with the front face 8 c of the anvil 8.

In this embodiment, the second connecting piece 12 b initially serves toreceive the introducer 10 as shown in FIG. 2 by screwing thecomplementary threaded element 13 b to the distal end of the secondrigid guide tube 13 to arrive at the configuration of FIGS. 2A and 5A inwhich the stop 15 b arrives near the downstream end of the stent 1inside the first guide tube 12. At this point, the pusher rod 15 a isactuated by relative translation of the second rigid guide tube 13 withrespect to the handle 14 through an indentation 13 c along the secondrigid tube 13. This translation is controlled by actuation of the pusherrod 14 a, to expel the stent 1 out of the first guide tube 12 as shownin FIG. 2B. At this point, the second connecting piece 12 b is locatedapproximately at the free end of the upstream part 100 a of the boweland is therefore in position to receive the anvil 8 via theinterposition of an adapter 7 as shown in FIGS. 7A to 7C. Theanastomosis is then performed with the stapler 9 as described withreference to FIGS. 4A to 4C. Then, the first guide tube 12—anvil8—stapler 9 is removed from outside the patient at the anal orifice tothe configuration shown in FIGS. 6 and 7D. In FIG. 7D, the stapler isshown downstream of a downstream segment of the intestine 100 b as aschematic illustration with the understanding that the stapler 9 isactually removed from the intestine via the rectum.

In this embodiment, preferably, the sheath 2 and the suction tube 3 arenot attached directly to the end of the deformable tube 12 in 2 b and 3b but via a tie such as a suture (not shown).

Example 2

FIGS. 8A-8B, 9A-9B, 10A-10C and 11A-11B illustrate the distinguishingfeatures of a second embodiment of a complex device according to theinvention.

In this second embodiment, the downstream ends of the sheath 2 and thesuction tube 3 are attached to a first connecting piece 11 positionedjust outside the downstream end of the stent 1.

FIGS. 8A and 8B show two variants of the arrangement of the sheath 2 andof the suction tube 3 inside the stent 1. In both cases, the sheath 2and the suction tube 3 are initially arranged inside the stent. In thefirst preferred variant of FIG. 8A, the suction tube 3 and the sheath 2are simply attached to a tubular part 11 a at the distal end of thefirst connecting piece 11 and folded inside the stent 1, with thesuction tube 3 not being wound onto the tubular part 11 a as in thesecond variant of FIG. 8B. The various stages of implementation of thecomplex device according to the invention in this second embodiment areillustrated in relation to this second variant of FIG. 8B but can betransposed to the variant of FIG. 8A. The tubular part 11 a of theconnecting piece 11 initially fits inside the stent 1 at its downstreamend and the larger diameter part lib serves as a support for the stop 15b of the pusher rod for the insertion phase and then serves for thereversible fixing of the connecting piece 11 against the front face 8 cof the anvil 8 for the stapling phase and making of the anastomosis.

In this embodiment, the complex device according to the inventioncomprising the assembly of the protective device 5 and the firstconnecting piece 11, which assembly is independent of the first guidetube 12. Thus, the first guide tube 12 can be irreversibly fixed at theconnection piece 13 a to the distal end of the second rigid guide tube13 of the introducer 10 as shown in FIG. 9A.

FIGS. 9A and 9B show that initially the stop 15 b at the distal end ofthe pusher rod 15 a is applied against the flat proximal face bib of thefirst connecting piece 11 to expel the stent 1 out of the first guidetube 12 by translation of the pusher rod 15. Then, as shown in FIG. 10A,the introducer 10 is removed from the upstream bowel section 100 a toleave the first connecting piece 11 at the anastomosis site 101. It isadvantageous that the stop 15 a is reversibly glued to the firstconnecting piece 11 to allow partial unfolding of the sheath 2 and thesuction tube 3 during the preliminary partial removal of the introducer10 until the part 11 reaches the anastomosis site as shown in FIG. 10B.At this point the anvil 8 is reversibly fixed against the firstconnecting part 11, for example by reversible bonding. The anastomosisis then performed as in example 1 and as shown in FIGS. 4A to 4C untilthe situation shown in FIGS. 11A and 11B is reached in which theassembly attached to the first connection piece 11—anvil 8—stapler 9 isremoved to deploy the sheath 2 and the tube 3 completely downstream ofthe stent 1 and downstream of the anastomosis 101 to the anal orificewhere the sheath 2 and the suction tube 3 are separated from the firstconnection piece 11 with the scissors 16. In FIGS. 11A-11B, the stapler9 is shown downstream of a downstream segment of intestine 100 bschematically with the proviso that the stapler 9 is actually insertedand removed from the intestine via the rectum with the handle 9 dremaining outside the rectum.

In an example of a simplified version (not shown), the flexible sheath 2and two suction tubes 2 are initially arranged within said first tube 12but entirely outside the stent, downstream of the stent said stent beingheld in radial compression within said first guide tube, and the twosuction tubes 2 being arranged so as to be able to extend diametricallyopposite to said stent and outside the sheath.

What is claimed:
 1. A device for introducing an implantable device intoan intestine to protect an anastomosis site, the device comprising: afirst guide tube configured to hold the implantable device therein in aradially compressed state, the first guide tube comprising a distal endconfigured to be introduced through an anal orifice into the intestineto a position upstream of the anastomosis site; a second guide tubepositioned proximal to the first guide tube; a stop between the firstguide tube and the second guide tube, the stop having a diameter largerthan that of the first guide tube and the second guide tube; and ahandle positioned, in a delivery state, proximal to the second guidetube, wherein a distance between the first guide tube and the handle isconfigured to be reduced to release the implantable device out of thedistal end of the first guide tube at the position upstream of theanastomosis site for implanting the implantable device for protectingthe anastomosis site.
 2. The device of claim 1, wherein the second guidetube is configured to be moved into the handle when the distance betweenthe first guide tube and the handle is reduced.
 3. The device of claim1, wherein the second guide tube comprises a guide groove configured tocontrol translation.
 4. The device of claim 1, wherein the distal end ofthe first guide tube comprises cut-out tabs configured to block thedistal end of the first guide tube.
 5. The device of claim 4, whereinthe cut-out tabs are elastically deformable to permit the implantabledevice to be deployed therethrough.
 6. The device of claim 5, whereinthe cut-out tabs form a tulip configuration.
 7. The device of claim 1,wherein the handle comprises an actuator configured to controllongitudinal translation.
 8. The device of claim 7, wherein the actuatorcomprises a button on the handle.
 9. The device of claim 1, furthercomprising a pusher disposed within the first guide tube, the pusherconfigured to cause the implantable device to be released out of thedistal end of the first guide tube when the distance between the firstguide tube and the handle is reduced.
 10. The device of claim 1, whereinthe implantable device comprises a stent coupled to a sheath, the stentconfigured to expand upon release from the distal end of the first guidetube to anchor the implantable device at the position upstream of theanastomosis site such that the sheath protects the anastomosis site. 11.The device of claim 10, wherein the implantable device comprises atleast one suction tube configured to permit application of suction atthe stent to increase anchoring force at the stent.
 12. The device ofclaim 11, wherein the at least one suction tube comprises two suctiontubes, each suction tube being connected to a vacuum chamber between thestent and the sheath for maintaining vacuum in the vacuum chamber. 13.The device of claim 1, wherein the device is configured to introduce theimplantable device before an anastomosis is carried out at theanastomosis site.
 14. The device of claim 1, wherein the distancebetween the first guide tube and the handle is configured to be reduceduntil the stop is positioned at or near the handle.
 15. A method forintroducing an implantable device into an intestine to protect ananastomosis site, the method comprising: introducing a distal end of afirst guide tube of an introducer device through an anal orifice intothe intestine to a position upstream of the anastomosis site, the firstguide tube having the implantable device disposed therein, theintroducer device comprising a second guide tube positioned proximal tothe first guide tube and a stop between the first guide tube and thesecond guide tube, the stop having a diameter larger than that of thefirst guide tube and the second guide tube; and using a handle to reducea distance between the first guide tube and the handle to release theimplantable device out the distal end of the first guide tube at theposition upstream of the anastomosis site for implanting the implantabledevice for protecting the anastomosis site.
 16. The method of claim 15,further comprising applying and maintaining suction to the implantabledevice at the position upstream of the anastomosis site to anchor theimplantable device within the intestine.
 17. The method of claim 15,wherein the implantable device comprises a stent coupled to a sheath,and wherein the stent expands upon deployment from the distal end of thefirst guide tube to contact an intestine wall at the position foranchoring.
 18. The method of claim 15, wherein using the handlecomprises actuating an actuator at the handle to control longitudinaltranslation.
 19. The method of claim 15, wherein reducing the distancebetween the first guide tube and the handle causes the second guide tubeto move into the handle.
 20. The method of claim 15, wherein releasingthe implantable device comprises elastically deforming cut-out tabs atthe distal end of the first guide tube to permit the implantable deviceto be deployed therethrough.